Devices

FDA Wants Abbott Cybersecurity Fixes

Attorneys Cameron Abbott and Giles Whittaker (K&L Gates) say FDA is threatening legal action against Abbott if the company doesn’t address safety and security issues in implanted cardiac devices sold by its recently acquired St. Jude Medical unit. Writing in an online blog post, the two say an agency Warning Letter gave the company 15 days to submit a plan to address errors in the products’ design that could allow hackers to tamper with the settings and drain the device’s batteries, which were thought to have contributed to the cause of a death.

“Many of the cybersecurity concerns first came to light after medical device security research firm MedSec submitted a report outlining a variety of alleged security flaws in St. Jude Medical products to investment firm Muddy Waters Research,” the attorneys write. The research firm publicly announced the product design failures while short-selling St. Jude Medical stock to capitalize on the expected market response, they say.

The attorneys write that companies that don’t make cybersecurity considerations central to their business model risk having their inadequacies called out in a public forum as well as facing liability litigation.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome